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Compliance Specialist
23 hours ago
TekwissenGroup Cypress, United States**Role Summary**: · - This role will be focused on delivering high caliber results, on predetermined timelines, while assisting to manage workflow processes related to all aspects of Contract Compliance Management. · - This role must be well organized, have high digital acumen an ...
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Compliance Specialist
1 week ago
Avanath Long Beach, United States**Overview** · Avanath is proud to be named one of the top property management companies to provide affordable housing for the work force. · - Cultivating the American Dream _is the purpose that binds the Avanath team. At Avanath, every day is an opportunity to make a difference ...
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Regulatory Compliance Specialist
2 weeks ago
Vast Long Beach, United StatesAt Vast, our mission is to contribute to a future where billions of people are living and thriving in space. We are building artificial gravity space stations, allowing long-term stays in space without the adverse effects of zero-gravity. Our initial crewed space habitat will be ...
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Orr Compliance Specialist
5 days ago
McKinley Children's Center San Dimas, United States**McKinley**:Youth, Family, and Community are what we are all about We offer a great working environment and benefits package McKinley encourages growth so that you can Be your Best H.U.M.A.N. · At McKinley employees share a set of guiding principles: We embrace a culture that is ...
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Export Compliance Specialist
6 days ago
Leonid Group Ltd Irvine, United StatesThis is an exciting opportunity to join a global leader in aerospace and defense renowned for its groundbreaking technologies and solutions. · Our client specializes in providing cutting-edge engines, systems, and equipment for both civil and military aircraft. With a steadfast c ...
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Regulatory Compliance Specialist
2 weeks ago
Irvine Ranch Water District Irvine, United StatesIrvine Ranch Water District is currently accepting applications for a Regulatory Compliance Specialist in our Regulatory Compliance Department. The District. Irvine Ranch Water District (IRWD) is a progressive, values-driven agency, with an internati Compliance Specialist, Regula ...
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Regulatory Compliance Specialist
1 day ago
Irvine Ranch Water District Irvine, United StatesGeneral Description · Irvine Ranch Water District is currently accepting applications for a Regulatory Compliance Specialistin our Regulatory Compliance Department. · The District · Irvine Ranch Water District (IRWD) is a progressive, values-driven agency, with an international r ...
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Export Compliance Specialist
4 days ago
Leonid Group Ltd Irvine, United StatesThis is an exciting opportunity to join a global leader in aerospace and defense renowned for its groundbreaking technologies and solutions. · Our client specializes in providing cutting-edge engines, systems, and equipment for both civil and military aircraft. With a steadfast ...
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SR. Compliance Specialist
1 week ago
Insight Global Irvine, United StatesInsight Global is looking for a Sr. Compliance Specialist to work for one of our aerospace clients based in California. The Sr. Compliance Specialist, Export and Import works in the International Trade Compliance Department ("ITCD") to provide comprehensive and proactive export c ...
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Quality Compliance Specialist
2 weeks ago
Planet Pharma Irvine, United States12 month contract, pay $34/hr · Summary: · The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate · Key Responsibilities: · Manage customer rel ...
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Senior Compliance Specialist
5 days ago
The Capital Group Companies , Inc. Irvine, United States'I can succeed as a Senior Compliance Specialist at Capital Group.'As a Senior Compliance Specialist on our Client Services team, you will oversee and help negotiate contracts and provide compliance support for a number of Capital Group's investment offerings and services. Wearin ...
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Senior Compliance Specialist
1 week ago
The Capital Group Companies , Inc. Irvine, United States"I can succeed as a Senior Compliance Specialist at Capital Group." · As a Senior Compliance Specialist on our Client Services team, you will oversee and help negotiate contracts and provide compliance support for a number of Capital Group's investment offerings and services. Wea ...
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Quality Compliance Specialist
2 weeks ago
Ledgent Technology Irvine, United StatesQuality Compliance Specialist · Duration - 1 Year, Contract, W-2 · Location - Onsite in Irvine, CA · Max Pay - $30 - $36 an hour · Key Responsibilities: · Assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; processing 30-50 ...
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SeniorQuality Compliance Specialist
1 week ago
JobRialto Irvine, United States· Summary: · The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate · Key Responsibilities: · Manage customer relationships and expectation ...
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Regulatory Compliance Specialist
1 week ago
Irvine Ranch Water District Irvine, United StatesSalary : $81, $115,835.20 Annually · Location : Irvine, CA · Job Type: Full-Time Regular · Job Number: 00792 · Department: Regulatory Compliance · Opening Date: 05/01/2024 · Closing Date: 5/26/2024 11:59 PM Pacific · General Description · Irvine Ranch Water District is cur ...
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SeniorQuality Compliance Specialist
1 week ago
JobRialto Irvine, United StatesSummary:The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriateKey Responsibilities:Manage customer relationships and expectations during the co ...
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Quality Compliance Specialist
2 days ago
JobRialto Irvine, United States· Summary: · The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate · Key Responsibilities: · Manage customer relationships and expectation ...
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Quality Compliance Specialist
18 hours ago
Trinus Irvine, United StatesJob Description · Job DescriptionSummary: · The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate · Key Responsibilities: · Manage customer re ...
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Research & Development Compliance Specialist
1 week ago
Hochiki Group Buena Park, United States**Research & Development Compliance Specialist** · **Hochiki America Corporation - Buena Park, CA** · **About Hochiki America** · Hochiki America Corporation is part of the Hochiki Group, a global leader in fire protection technology with a century-long legacy that began in Japan ...
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Quality Assurance Compliance Specialist
2 weeks ago
Infosoft, Inc. Irvine, United StatesJob Title: Quality Compliance Specialist (Complaint Handling) · Pay Rate: $35 to $39.05/HR · Duration: 12 months · Location: Irvine, CA (Onsite) · Shift: 8 am PST to 5 pm PST (can come in earlier or later if needed, the team is flexible) · Our Client is a Global medical device Ma ...
SeniorQuality Compliance Specialist - Irvine, United States - JobRialto
Description
Summary:
The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate
Key Responsibilities:
Manage customer relationships and expectations during the course of complaint investigation and resolution process
Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations
Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered
Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions.
Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint
Additional Skills:
Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required
Proven expertise in MS Office Suite and ability to operate general office machinery
Excellent written and verbal communication skills and interpersonal relationship skills
Demonstrated problem-solving, critical thinking, and investigative skills
Full knowledge and understanding of Client policies, procedures, and guidelines relevant to quality compliance
Good knowledge of medical terms and human anatomy
Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
Ability to manage confidential information with discretion
Attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Work is performed independently on complex work and reviewed for accuracy and soundness
Education and Experience:
Bachelor's Degree or equivalent in related field
5-7 years of experience required
Education: Bachelors Degree